# K190303: AirSeal

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Mar 28, 2019 after 44 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K964171 (1997). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063367: 45L Core Insufflator, Model F114, W.O.M. World of Medicine AG (2007) Summary page 4.
- K172516: SurgiQuest AIRSEAL iFS System, Conmed Corporation (2018) Summary page 4.

## Most influential descendants
- K211104: AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set (2021), 0 descendants of its own

## Indications for use
The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric (≥ 20kg ) procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Source page: https://510kreport.com/device/K190303
Methodology: https://510kreport.com/methodology